The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01474200

Recruitment Status
:
Terminated
(Closed due to patient recruitment challenges. No interim analyses were completed; study closure was not related to any concerns about safety or futility.)

The purpose of the research is to determine if patients have fewer Heart Failure (HF) events after receiving Aquapheresis (AQ) therapy compared to intravenous (IV) diuretics up to 90 days of discharge from the hospital. Heart Failure events are defined as returning to the hospital, clinic or emergency department (ED) for treatment of HF symptoms.

The aim of the proposed AVOID-HF study is to confirm and expand the findings that fluid removal by AQ reduces HF rehospitalizations at 90 days as well as the length of these HF rehospitalizations. In the "Ultrafiltration Versus Intravenous Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure" (UNLOAD) study, the 90 day HF re-hospitalizations were pre-specified secondary end-points. AVOID-HF is designed with a primary end-point to determine if AQ reduces the number of HF events (Rehospitalization or unscheduled outpatient or emergency room treatment for HF) after discharge from index hospitalization compared to IV loop diuretics. AVOID will also explore days alive and out of the hospital as a secondary end-point, which was not done in UNLOAD. In other words, the AVOID-HF study is going beyond studying only the amount of fluid removal and will explore whether the modality of fluid removal influences HF outcomes.

Excess fluid from the patient is removed by isolated veno-venous ultrafiltration treatment using the Aquadex Flex Flow System

Device: Isolated veno-venous ultrafiltration (AQ)

Aquapheresis treatment (isolated veno-venous ultrafiltration) using the Aquadex FlexFlow System during index hospitalization until the patient's signs and symptoms of fluid overload have improved to the satisfaction of the treating physician. Ultrafiltration rates, duration and frequency of treatment are dependent on the amount of patient fluid excess and on the rate of fluid movement from the interstitial spaces into the vascular compartment during Aquapheresis (Plasma Refill Rate, or PRR)

Other Names:

Aquapheresis

Ultrafiltration

Aquadex FlexFlow System

Gambro UF Solutions

Active Comparator: IV Loop Diuretics (LD)

Excess fluid from the patient is removed by IV (Intravenous) loop diuretic treatment

Drug: IV Loop Diuretics (LD)

IV Loop Diuretics treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload. This includes furosemide or other IV loop diuretics administered at equivalent doses to furosemide. Patients will receive either a twice daily IV bolus or continuous IV LD infusions according to the high dose protocol of the"Diuretic strategies in patients wth acute decompensated heart failure" (DOSE) trial.

EFFICACY: Time to Freedom From Congestion [ Time Frame: Index Hospitalization, an average of 8 days ]

Time from hospital admission to time patient is free of congestion in the hospital. Freedom from congestion is defined as jugular venous distention of < or equal to 8 cm, with no orthopnea and with trace peripheral edema or no edema. Measurement taken every 24 hours after treatment initiation.

EFFICACY: Freedom From Congestion [ Time Frame: Index Hospitalization, an average of 8 days ]

Defined as jugular venous distention of < or equal to 8 cm, with no orthopnea, and with trace peripheral edema or no edema at hospital discharge

EFFICACY: Changes in B-type Natriuretic Peptide (BNP) Levels Over Time [ Time Frame: Baseline and at 72 hours from baseline, hospital discharge and at 90 days after hospital discharge ]

Change in BNP levels over time at 72 hours, discharge, and 90 days after discharge.

CLINICAL: Total Number of Days Rehospitalized for Heart Failure (HF) at 30 and 90 Days After Discharge [ Time Frame: Within 30 days and 90 days after hospital discharge ]

Days rehospitalized for HF symptoms requiring hospital, emergency room or clinic treatment involving the use of IV diuretics and /or positive inotropic or vasodilator drugs.

CLINICAL: Total Number of Emergency Department (ED) or Unscheduled Office Visits at 30 and 90 Days After Discharge [ Time Frame: Within 30 days and 90 days after hospital discharge ]

Number of visits for HF symptoms requiring ED or clinic treatment involving the use of IV diuretics and /or positive inotropic or vasodilator drugs

CLINICAL: Total Number of Heart Failure (HF) Rehospitalizations at 30 and 90 Days After Discharge [ Time Frame: Within 30 days and 90 days after hospital discharge ]

Number of different times patient was admitted to hospital for HF symptoms within 90 days of index hospitalization discharge.

CLINICAL: Total Number of Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge [ Time Frame: Within 30 days and 90 days after hospital discharge ]

CV symptoms that required hospitalization for treatment within 90 days of index hospitalization discharge.

CLINICAL: Total Number of Days for Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge [ Time Frame: Within 30 days and 90 days after hospital discharge ]

The total number of days spent in the hospital due to CV related events at 30 days and 90 days from hospital discharge.

CLINICAL: All Cause Rehospitalization Rates at 30 and 90 Days [ Time Frame: Within 30 days and 90 days after hospital discharge ]

Any cause that required hospitalization for treatment within 90 days of index hospitalization discharge.

CLINICAL: Mortality Rates Within Index Hospitalization or Within 90 Days After Hospital Discharge. [ Time Frame: Time from randomization to 90 days post-hospital discharge ]

Death due to any cause.

CLINICAL: Days Alive and Out of Hospital at 30 and 90 Days After Discharge [ Time Frame: Within 30 and 90 days after hospital discharge ]

Number of days patients were alive and out of the hospital.

CLINICAL: Quality of Life Assessed Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30, 60 and 90 Days After Discharge [ Time Frame: Within 90 days after hospital discharge ]

Questionnaire assessed patients quality of life prior to index treatment versus timeframes following hospital discharge. Scores were transformed to a range of 0-100, in which higher scores reflect better health status.

CLINICAL: Global Clinical Score at 30 and 90 Days After Discharge [ Time Frame: Within 90 days after hospital discharge ]

KCCQ Questionnaire analysis based on patient's self-assessment of how they feel at various intervals compared to how they felt prior to index treatment. Scores were transformed to a range of 0-100, in which higher scores reflect better health status.

SAFETY: Changes in Renal Function (Serum Creatinine) After Treatment up to 90 Days After Randomization [ Time Frame: Within 90 days of randomization ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

18 years of age or older

Male or non-pregnant female patients

Admitted to the hospital with a primary diagnosis of acute decompensated heart failure (ADHF)

On regularly scheduled oral loop diuretics prior to admission

Fluid overload manifested by at least two of the following:

Pitting edema (2+) of the lower extremities

Jugular venous distention > 8 cm

Pulmonary edema or pleural effusion on chest x-ray

Paroxysmal nocturnal dyspnea or ≥ two- pillow orthopnea

Respiration rate ≥ 20 per minute.

Have received ≤ 2 IV loop diuretics doses before randomization

Must be able to be enrolled into the trial ≤ 24 hours of their admission to the hospital.

Provide written informed consent form as required by the local IRB (Institutional Review Board)